Kornimate/medical-research-clean huggingface dataset:
serum ngal as a predictor of clinical and endoscopic activity of inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases

Summary: ulcerative colitis (uc) and crohns disease (cd) represent the two major forms of inflammatory bowel disease (ibd), characterized by epithelial cell damage and prominent mucosal infiltration by inflammatory cells including granulocytes, macrophages, lymphocytes, and plasma cells.


Eligibility criteria:
inclusion criteria: ibd patients diagnosed by endoscopy. male and female gender. disease activity proven clinically and endoscopy . assiut university hospital patients exclusion criteria: * patients who refuse to contribute in this study pregnancy and breast feeding cancer patients renal pathology diabetes mellitus cardiovascular patients pancreatitis copd patients
facilitate the transition from passive feeding to active feeding in preterm infants through early play

Conditions: Immature Newborn; Feeding Behavior

Summary: the approach described here is based both on theoretical concepts and on the work of several teams of researchers. by positioning the baby and the appropriate adult, a speech bath, a sustained look and an expressive face, it is hypothesized that this early communication exercise will significantly improve the transition from passive feeding, active feeding of the premature child, from a qualitative and quantitative point of view.


Eligibility criteria:
inclusion criteria: * age of child at birth: \<32 wa justified by the greater prevalence of oral disorders in these children. * age of the child at the start of the study: 35 wa, ie at the beginning of the establishment of active feeding within the unit. exclusion criteria: * children with oral malformations * contra-indication to the realization to the alijeu (infection in progress, hemodynamic instability, etc.) * medical contraindications to oral diet

Keywords: feeding behavior
zeta : prospective observational study

Conditions: Metastatic Colon Cancer

Summary: primary objective - evaluate the efficacy in terms of progression-free survival (pfs) of aflibercept in combination with folfiri in patients treated routinely for metastatic colorectal cancer (mcrc) after failure of treatment with oxaliplatin + egfr. secondary objective * evaluate the efficacy of aflibercept in combination with folfiri on the 2-year overall survival rate and the objective response rate. * evaluate the tolerance profile of aflibercept in combination with folfiri. * observational study, national, multicenter, cohort, prospective without intervention on the therapeutic strategy.•

inclusion criteria * all patients expected to be treated with aflibercept in combination with folfiri for a mcrc, after failure of treatment with oxaliplatin + anti-egfr on the decision of the doctor (situation included in the framework of the ma of aflibercept) . * age ≥18 years * signature of the agreement for the collection of medical and personal data. (patients who have received folfirinox in the first line metastatic are allowed) note: failure is defined as progression during or within 6 months after discontinuation of oxaliplatin exclusion criteria : * concurrent participation in a clinical trial * patients who have previously received anti-vegf agents and / or aflibercept in one trial. * patients who received folfiri in the first metastatic line.

Eligibility criteria:
inclusion criteria * all patients expected to be treated with aflibercept in combination with folfiri for a mcrc, after failure of treatment with oxaliplatin + anti-egfr on the decision of the doctor (situation included in the framework of the ma of aflibercept) . * age ≥18 years * signature of the agreement for the collection of medical and personal data. (patients who have received folfirinox in the first line metastatic are allowed) note: failure is defined as progression during or within 6 months after discontinuation of oxaliplatin exclusion criteria : * concurrent participation in a clinical trial * patients who have previously received anti-vegf agents and / or aflibercept in one trial. * patients who received folfiri in the first metastatic line

Keywords: metastatic colon cancer
effectiveness of carbon filters to reduce the anesthetic gas concentration in an anesthetized patient

Conditions: Malignant Hyperthermia

Summary: malignant hyperthermia is a potentially fatal inherited disorder triggered by exposure to volatile anesthetic gases, most commonly recognized in children during anesthesia. carbon filters have been used to scavenge various gases. a new carbon filter (vapor clean, dynasthetics, llc, salt lake city, utah) with a 510(k) clearance specifically for scavenging anesthetic gases is being marketed, though the filter itself has never been studied in vivo. bench studies conducted by the manufacturer of the product demonstrate it is extremely effective in reducing the volatile gas output from an anesthesia machine within 2 minutes. this pilot study will measure the effect on volatile gas concentration in non-malignant hyperthermia susceptible patients. twelve (12) patients will undergo standard anesthetic induction using inhalational anesthetic (sevoflurane®) and maintained on 3% for 30 minutes to attain steady state concentrations.1 at that time, a total intravenous anesthetic technique will be started and maintained throughout the case. simultaneously a vapor clean filterset will be placed in the breathing circuit (inspiratory and expiratory limbs). volatile gas concentration will be measured and recorded. this research will determine the feasibility of using this carbon filter to quickly reduce the breathing circuit gas concentration of volatile anesthetic in the clinical setting. this is fundamental in establishing this as a key life saving measure in eliminating the stimulus in a malignant hyperthermia event.

see above.

Eligibility criteria:
inclusion criteria: * healthy asa ps i or ii children 2 years to 16 years old * having general anesthesia for approximately 1 hour or more exclusion criteria: * malignant hyperthermia susceptible patients (personal or family history) * patients with known neuromuscular disorders at high risk of malignant hyperthermia (e.g., muscular dystrophy) * egg or soy allergy * patient or parent refusal * pregnant patients

Keywords: malignant hyperthermia
clinical investigation evaluating the use of netsmart solution , incorporated to netsoins software, in the care and support of elderly people living in nursing homes

Conditions: Pressure Injury; Fall Prevention; Undernutrition; Drug Interaction

Summary: netsmart software is designed to help doctors, nurses and care assistants adapt the care of elderly people living in nursing homes to the following risks: * pressure injuries * undernutrition * interactions between different drugs * falls. the software analyzes the information in your medical records, alerts your medical team to any points of vigilance, and suggests appropriate recommendations. the study comprises 2 distinct phases: * an initial 4-month phase, during which the medical staff will simply assess whether the netsmart software's recommendations are relevant, without changing their current practice, i.e. they will continue to care for you as usual; * a second 6-month phase, during which your caregivers will follow the software's recommendations if they feel they are relevant, and potentially adapt your care.


Eligibility criteria:
inclusion criteria: * male or female, at least 70 years old * permanent resident at an investigation site for at least 6 months. * considered an at-risk patient, i.e. meeting at least one of the following criteria : * braden score \< 16 * at risk of pressure ulcer according to the investigator's judgment * at risk of undernutrition as judged by the investigator * undergoing at least 6 drug treatments * at risk of falls as judged by the investigator * affiliated with the french social security system * having given informed, dated and signed consent to participate in the investigation exclusion criteria: * patient with a life expectancy of less than 2 months as judged by the investigator * patient who is participating or has participated in another investigation or study involving the use of a medical device or drug within 30 days prior to inclusion
influence of modified diet, exercise and electrical swallowing muscle stimulation on swallowing function and quality of life in elderly patients with oropharyngeal dysphagia

Conditions: Oropharyngeal Dysphagia

Summary: tasks of biomedical research: 1. to determine the severity of oropharyngeal dysphagia and the risk of aspiration in elderly patients. 2. to evaluate the quality of life of older patients with oropharyngeal dysphagia by performing validation of the lithuanian version of the quality of life questionnaires in patients with oropharyngeal dysphagia. 3. to evaluate the severity of oropharyngeal dysphagia in elderly patients, the risk of aspiration, and quality of life after interventions. data on the sex, age and disease of the swallowing disorder will be collected. no processing of other personal data and health indicators is planned. all data will be collected in questionnaires. the data will be depersonalized by giving the patient a code. the results and conclusions of the research will be described in the doctoral dissertation and will be used for scientific articles.


Eligibility criteria:
inclusion criteria: * patients 60 years of age and older; * swallowing disorder suspected during hospitalization - oropharyngeal dysphagia; * patient's written consent. exclusion criteria: * severe oropharyngeal dysphagia (when feeding into the stomach through a nasogastric tube is required); * significant respiratory or heart failure: dyspnoea (respiratory rate\> 20 rpm, spo2 \ 100 rpm); * very severe malnutrition (severe exhaustion, severe signs of sarcopenia); * final stage of oncological disease; * severe dementia (short mental test (mmse) \<10 points); * ingestion assessment with a fibroendoscope (fees) did not reveal any swallowing problems (no dysphagia).
an open multiple dose titration study in patients with pulmonary hypertension

Conditions: Hypertension, Pulmonary

Summary: this is a study to demonstrate the feasibility of an individual dose titration scheme based on the systolic blood pressure with a dose range from 1.0 mg tid to 2.5 mg tid. patients suffering from chronic thromboembolic pulmonary hypertension (cteph) or pulmonary arterial hypertension (pah) will be included. after diagnosis by an expert center, patients receive medication three times a day starting with 1.0 mg tid. the first tablets are given in the hospital, then the patients are allowed to go home and take the medication at home. after 2 weeks, patients return to the hospital for an ambulatory visit and the dose may be increased based on the actual condition of the patient (blood pressure and adverse events). several measurements will be performed to test the efficacy of the drug and whether there are any unwanted reactions to the drug (blood tests, ecg, 6 minute walk test, imaging by echo, quality of life scores). the dose of the drug will then be increased further until unwanted effects may occur or the blood pressure drops to low. the highest dose tested will be 2.5 mg tid. after 12 weeks the patient is going to stay in the hospital again and a right heart catheter is performed to examine the changes in hemodynamics after 12 weeks of treatment with the drug. if the patients give their consent they can enter a long-term extension trial continuing on bay63-2521 with the dose reached after 12 weeks. every 3 months an ambulatory visit at the specialist center will be performed including measurements of safety (blood tests, ecg, clinical assessment) and efficacy (6 minute walk test, borg dyspnea scale, nt-pro bnp). blood tests and ecg have been removed begin of 2013 as safety parameter by amendment 7; furthermore borg dyspnea score and nt-probnp have been removed as efficacy parameter. initially the inclusion of ten patients suffering from chronic thromboembolic pulmonary hypertension (cteph) or pulmonary arterial hypertension (pah) was planned. later on the patient number was amended and 75 patients entered the trial. furthermore the trial duration was extended and a long term treatment with bay63-2521 was offered to the patients. finally 68 patients moved over to the long term extension period of the trial.

specification of primary outcome measures for long-term safety and tolerability: adverse events, blood pressure and heart rate, 12 lead ecg, clinical chemistry and hematology, troponin i

Eligibility criteria:
inclusion criteria: * patients with cteph or pah in nyha class ii or iii exclusion criteria: * patients with pde 5 inhibitor or prostacycline pretreatment, relevant pulmonary diseases, relevant cardiac diseases, severe coagulation disorders, moderate to severe hepatic or renal insufficiency, pregnancy, hypotension

Keywords: pulmonary arterial hypertension (pah) chronic thromboembolic pulmonary hypertension (cteph)
levetiracetam prophylaxis in brain tumor resection pilot

Conditions: Seizures; Brain Tumor

Summary: this study aims to evaluate feasibility of a double-blind randomized controlled trial for levetiracetam prophylaxis for prevention of seizure in the perioperative phase of brain tumor resection.


Eligibility criteria:
inclusion criteria: * adult age 18 years or older * undergoing craniotomy for a brain tumor * intra-axial tumor location * supratentorial tumor location exclusion criteria: * documented seizure history or epilepsy diagnosis * currently taking an antiepileptic medication * unable to take levetiracetam (e.g. allergy, inability to swallow) * inability to obtain consent from participant or substitute decision maker prior to surgery * renal impairment with egfr less than 50 * pregnancy
mild traumatic brain injury discrimination

Conditions: Brain Concussion

Summary: evaluation of the utility of a multi-modal assessment tool in distinguishing between individuals with and without a history of mild traumatic brain injury.

this was a preliminary validational study of a multi-modal concussion assessment battery incorporating eye-tracking, balance, and neurocognitive tests on a new hardware platform, the computerized brain injury assessment system (cbias). using receiver operator curve (roc) analyses, 1) a subset of the most discriminating neuro-physiological assessment tests involving smooth pursuit eye motion (spem) tracking errors, corrective saccade counts, a balance score ratio sensitive to vestibular balance performance and two neurocognitive tests of response speed and memory/incidental learning, was identified, 2) the enhancement in discriminatory capability of detecting concussion-related deficits through the combination of the identified subset of assessments was demonstrated, and 3) the effectiveness of a robust and readily implemented global scoring approach was demonstrated for both eye track and balance assessment tests. these results are significant in introducing a comprehensive solution for concussion assessment that incorporates an economical, compact and mobile hardware system and an assessment battery that is multi-modal, time efficient and whose efficacy has been demonstrated on a preliminary basis. this represents a significant step toward the goal of a system capable of making a dependable return-to-play/duty determination based on concussion likelihood.

Eligibility criteria:
inclusion criteria: * military personnel * age 18 to 45 * diagnosis of mtbi within past 5 years * rancho los amigos scale score of 7 or above exclusion criteria: * non-military individuals * below age 18 or older than 45 * no diagnosis of mtbi within past 5 years * rancho los amigos scale score of 6 or below

Keywords: injury brain traumatic mild mild traumatic brain injury
a phase iii randomized trial of topical vaginal fluorouracil (5-fluorouracil, 5-fu) maintenance therapy versus observation after standard treatment for high-grade cervical dysplasia in hiv-infected women

Conditions: HIV Infections; Cervix, Dysplasia

Summary: to determine the efficacy and safety of intravaginal fluorouracil administered as prophylaxis in hiv-infected women who have received standard ablative therapy (surgery) for high-grade cervical dysplasia (pre-cancer of the cervix; cervical intraepithelial neoplasia). to correlate time to recurrence of cervical dysplasia with t-cell function. women with hiv infection are at greater risk for cervical dysplasia. because of the likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer, there is an urgent need to develop appropriate therapies.

women with hiv infection are at greater risk for cervical dysplasia. because of the likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer, there is an urgent need to develop appropriate therapies. patients are randomized to receive either intravaginal fluorouracil or no treatment (observation only). fluorouracil cream is self-administered via applicator at biweekly intervals for 6 months. patients are evaluated for recurrent cervical dysplasia by cytology and colposcopy with or without biopsy.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * antiretrovirals (azt, ddi, ddc) and immunomodulators (interferon and interleukin). * prophylaxis or treatment for opportunistic infections. * vaginal antifungal agents or other indicated vaginal medications (although not permitted on day of fluorouracil application). * contraceptives. * acyclovir (prophylaxis or treatment) in patients with a history of primary or recurrent genital herpes. patients must have: * hiv infection. * prior cervical dysplasia (grade ii or iii cervical intraepithelial neoplasia) successfully treated with an ablative procedure within the past 12 weeks. * patients less than 18 years of age must have consent of parent or guardian. exclusion criteria co-existing condition: patients with the following symptoms and conditions are excluded: * untreated or persistent vaginal or vulvar dysplasia. * colposcopy or biopsy inconclusive or positive for dysplasia. * active genital ulcerative disease such as syphilitic chancre or herpes ulcer. * adenocarcinoma in situ. concurrent medication: excluded: * cytotoxic chemotherapy for malignancy. * high-dose steroids (\> 10 mg/day prednisone or its steroid equivalent). patients with the following prior conditions are excluded: * malignancy requiring cytotoxic chemotherapy within the 3 months prior to study entry. * prior hysterectomy. * history of allergic reaction or severe hypersensitivity to fluorouracil. prior medication: excluded: * fluorouracil (systemic or topical) within 3 months prior to study entry.

Keywords: acquired immunodeficiency syndrome aids-related complex fluorouracil cervix dysplasia cervix diseases
the effect of a lighting intervention on sleep in parkinson disease

Conditions: Parkinson Disease; Sleep Disturbance

Summary: 50 participants with parkinson's disease will be recruited to complete actigraphy studies to assess sleep disturbances. for this, participants will wear an actigraph for seven days. thirty of these participants with sleep disturbance will go on to receive a tailored lighting intervention (tli) to assess the effect on sleep, fatigue, and circadian entrainment via urinary melatonin levels.

participants will undergo one week of baseline data collection using the actigraph and light meter and one night of an overnight urine collection. at the completion of the baseline week, the lighting intervention will be installed in the participants' home. participants will be exposed to the lighting intervention for 2 hours each morning after awakening for 8 weeks. during the last week of the lighting, participants will be asked to wear the actigraph and light meter again for 7 days and collect one overnight urine sample. participants will complete questionnaires before and after the intervention to further assess its effects.

Eligibility criteria:
inclusion criteria: * diagnosis of parkinson's disease and difficulties with sleep and/or cognition exclusion criteria: * there are no exclusion criteria
belotecan and cisplatin in treating patients with previously untreated, extensive-stage small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. belotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. giving belotecan together with cisplatin may kill more tumor cells. purpose: this phase ii trial is studying how well belotecan works when given together with cisplatin in treating patients with previously untreated extensive stage small cell lung cancer.

objectives: primary * to assess the antitumor efficacy, in terms of objective response rate, of belotecan hydrochloride and cisplatin in patients with previously untreated extensive-stage small cell lung cancer. secondary * to assess additional evidence of antitumor activity as measured by overall and progression-free survival of these patients. * to determine the safety and tolerability of this drug combination in these patients. outline: patients receive cisplatin iv on day 1 and belotecan hydrochloride iv on days 2-4.treatment continues in the absence of disease progression or unacceptable toxicity.

Eligibility criteria:
disease characteristics: * histologically confirmed small cell lung cancer meeting the following criteria: * extensive-stage disease * previously untreated disease * at least one measurable disease * no brain or leptomeningeal metastasis patient characteristics: * ecog performance status 0-2 * life expectancy ≥ 12 weeks * anc ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 * hemoglobin ≥ 9.0 g/dl * total bilirubin ≤ 1.5 mg/dl * alt and ast ≤ 2.0 times upper normal limit (uln) (≤ 5.0 times uln in the presence of liver metastasis) * alkaline phosphatase ≤ 2.0 times uln * creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 ml/min * no active infection requiring intravenous antibiotics * no other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or in situ cancer * no other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, interfere with the interpretation of study results, or make the patient ineligible for study entry, in the judgment of the investigator prior concurrent therapy: * no prior chemotherapy or radiotherapy * no other concurrent chemotherapy, radiotherapy, or immunotherapy

Keywords: extensive stage small cell lung cancer